MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE manufactured by Baxter Healthcare Corporation.
[185126219]
The reported product is an unknown baxter transfer set. (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185126220]
A peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis. The breach in aseptic technique was further described as transfer line damage due to? Secondary to manipulation?. The peritonitis was manifested by cloudy effluent. One day prior to the peritonitis event, the patient was hospitalized for another indication. The same day as event onset, the patient was treated with intraperitoneal (ip) vancomycin and ip amikacin for the peritonitis (no further details). On an unknown date, during hospitalization, the patient experienced septic shock and was transferred to the intensive care unit for inotropic support. Eight days after the peritonitis event, the patient passed away. The cause of death was reported as due to sepsis. It was not reported an autopsy was not performed. It was not reported if the peritonitis was resolved prior to death. Pd therapy was ongoing prior to death; however, it was not reported if the patient was performing therapy at the time of death. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01744 |
| MDR Report Key | 9884429 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | NI NI |
| Manufacturer City | NI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
| Product Code | KDJ |
| Date Received | 2020-03-26 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2020-03-26 |